Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04396301
Collaborator
(none)
30
1
2
7.9
3.8

Study Details

Study Description

Brief Summary

Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
Phase 3

Detailed Description

in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fydrane group

Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used.

Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
Other Names:
  • Mydrane
  • No Intervention: Reference group:

    not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively.

    Outcome Measures

    Primary Outcome Measures

    1. safety of intracameral Fydrane on endothelial cell count [3 weeks postoperative]

      evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative

    Secondary Outcome Measures

    1. effect of Fydrane on pupil diameter during phacoemulsification [pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)]

      Fydrane Efficacy in achieving and maintaining mydiasis, is evaluated by measuring pupil diameter using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • medium density cataract (nuclear II to III)
    Exclusion Criteria:
    • soft or hard density cataract (nuclear I or IV)

    • history of ocular trauma or previous intraocular surgery

    • iatrogenic, congenital or traumatic cataract

    • associated eye disease e.g. pseudoexofoliation syndrome

    • associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy

    • associated systemic disease that can affect endothelium,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University - Kasr Alainy hospital Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Elshewy, Dr, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04396301
    Other Study ID Numbers:
    • CU-oph-02-2019
    First Posted:
    May 20, 2020
    Last Update Posted:
    May 20, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Elshewy, Dr, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 20, 2020